Dressing and an epidermal positioning mechanism and method for using same

ABSTRACT

A dressing and an epidermal lifting mechanism for use with an application to a predetermined epidermal surface and methods of using same. The epidermal lifting mechanism comprises a strip of material having a first end portion of a predetermined shape, a second end portion of a predetermined shape, and middle portion coupling the first end portion to the second end portion. The first end portion and the second end portion each include a side including an adhesive layer. An overlaying, non-adhesive barrier layer may be located between a portion of the adhesive layer and an end portion.

RELATED APPLICATION

This application is a CIP of U.S. application Ser. No. 09/180,572 filed11 Jan. 2000, now U.S. Pat. No. 6,470,883 which claims the benefit ofPCT Application Ser. No. PCT/US97/00868 filed 17 Jan. 1997, which claimsthe benefit of Provisional Application Ser. No. 60/017,258 filed May 10,1996.

BACKGROUND OF THE INVENTION

The present invention relates generally to devices that may be used inthe healing arts and arts generally related thereto. More specifically,the present invention relates to devices which may be used for a varietyof purposes including but not limited to dressings for wounds, bandages,drug delivery systems, epidermal lifting mechanisms, and positioningmechanisms for positioning epidermal layers of skin on humans and/oranimals in a predetermined manner. The present invention is thusbelieved to have application in the medical and veterinary sciences.

Several forms of the present invention relate to epidermal liftingmechanisms and methods for increasing the flow of gases into the humanbody and more specifically to an epidermal lifting mechanism and methodfor allowing more oxygen to pass through the nasal cavity thusincreasing both the flow of oxygen into the lungs and the flow of airexhaled from the lungs. Consequently, embodiments of the presentinvention are also related to a group of devices which are sometimescalled nasal dilators. The present invention provides a comfortable andeffective device for allowing increased gas flow rates through the nasalpassages and into the lungs.

Additionally, the present invention is an improvement in the field ofbandages and suturing aids in that a person may use the presentinvention to hold the ends of a wound together or apart for the purposesof suturing or cleaning the wound and/or incision. Further, the deviceof the present invention may be used to apply medicine or anti-bacterialagents to a wound or incision. Also, some embodiments of the presentinvention may be used to isolate a wound or burn in a sterileenvironment while allowing access to the wound area for purposes such asirrigating the wound. Further, some embodiments of the present inventionmay be used to stabilize the wound or burn area so that the skin aroundthe wound or burn does not stretch with the movement of an individualand thus prevents further damage to the wound during the healing processand allows for more effective healing of the wound or burn.

SUMMARY OF THE INVENTION

The present invention has many applications. The present invention maybe generally described as a structure for aiding in the followingactivities: as an epidermal lifting mechanism for providing a liftingforce to a predetermined area of the epidermis, such as the area locatedto either side of the bridge of a person's nose to provide an increasedflow rate of gas through (inhaled and exhaled) the nasal passage, e.g.,a nasal dilator; a structure for aiding in keeping an incision open; astructure for aiding in keeping a wound open for cleansing; a structurefor aiding in keeping the ends or edges of an incision or wound inclose, neat, even, alignment by the application of an even pressureacross the wound, burn, or incision, so that the area requiringtreatment may heal, or be sutured and closed, neatly and thus developminimal scar tissue; or as an epidermal positioning mechanism as adevice for applying medicine to a wound or other desired place on theepidermis of a human or animal.

With respect to the invention's applications as a dressing the inventionmay be generally described as comprising: a first section, a secondsection, and a third section. Of these three sections, the first sectionis coupled to the second section and the second section is coupled tothe third section. The second section comprising an elastic materialwith the first section and the third section each having a first side;and a predetermined portion of the first side including an adhesivelocated thereon. The second section of the invention may include aplurality of openings of a predetermined size and predetermined shape.

It should be noted that the predetermined shape or shapes of theopenings may be spatially organized in a predetermined manner respectiveto each other. This is because in one embodiment of the presentinvention the second section is located between the first and thirdsections and is preferably composed of an elastic material. By placingopenings in the elastic material at predetermined locations the strengthof the elastic material, when the elastic material is stretched, may bevaried and the distribution of force across the elastic material may byvaried. Also, the openings can be used to provide a visual reference toa user of the amount of stress being placed upon the second section andwhether or not that section has been stretched sufficiently or beenstretched too much since the shape of the openings will change inresponse to the degree to which the elastic material is stretched. Sucha visual reference would be useful to medical personnel where, e.g., itis desirable for a predetermined amount of pressure to be applied to awound.

Further, the second section includes a first margin (if the secondsection is round then there is structurally just one annular margin nearat least a portion of the perimeter of the second section) and a secondmargin. The first section may be integral or coupled to the secondsection at the first margin; and the third section may be integral orcoupled to the second section at the second margin.

Preferably, but not necessarily, the first section and the third sectionare laminated materials comprising a first layer, a second intermediatelayer, and a third layer; with the third layer including the first sidecoated with adhesive and protected prior to use by a silicone releaseliner. The second section includes a first margin and a second margin.The first section includes a first channel located between the firstlayer and the third layer of the first section for receiving the firstmargin. The second section includes a second channel located between thefirst layer and the third layer of the second section for receiving thesecond margin. The second intermediate layer comprising an adhesivematerial. The first margin and the second margin of the second sectionrespectively including at least one opening and the first marginengaging the second intermediate layer in the first channel and theadhesive material extending through the opening of the first margin; andthe second margin engaging the second intermediate layer in the secondchannel and the adhesive material extending through the opening of thesecond margin.

The first and third layer of the first section and the first and thirdlayer of the third section preferably being an inelastic material insome embodiments. The inelastic material may be of any suitable materialsuch as a TYVEC brand type of material.

Alternatively, the dressing mechanism may be described as comprising: afirst section, a second section, and a third section such that the firstsection is coupled to the second section and the second section iscoupled to the third section. The first section and the third sectioncomprising an elastic material and the first section and the thirdsection each having a first side; and a predetermined portion of thefirst side including an adhesive located thereon.

Further, the second section includes at least one opening of apredetermined size and the first section and the third section eachinclude at least one opening comprising a predetermined shape. Aspreviously noted the openings of predetermined shape are spatiallyorganized in a predetermined manner respective to each other.

Also, the second section may include at least one margin and the firstsection and the third section each have a respective margin area. Thefirst section margin is coupled to the second section at a firstpredetermined portion the margin of the second section. The thirdsection margin being coupled to the second section at a secondpredetermined portion of the margin of the second section.

Preferably, the second section is a laminated material comprising atleast a first layer, a second intermediate layer, and a third layer; thethird layer including the first side. The first section and the thirdsection including a first section margin and a third section margin.Both the first section margin and the third section margin beingcomposed of an elastic material. The second section including at leastone channel located between the first layer and the third layer of thesecond section at the second section margin for receiving the margins ofthe first and third sections. The second intermediate layer comprisingan adhesive material. The first section margin and the third sectionmargin respectively including at least one opening and the margins ofthe first and third sections engaging the second intermediate layer inthe channel at the respective first predetermined margin area and secondpredetermined margin area so that the adhesive material extends throughthe openings formed in the material which makes up the first and thirdsection margins. The first and third layer of the second section may, inthis embodiment, comprises an inelastic material. The inelastic materialmay be a polyester.

Further, the second section includes at least one opening or at leastone generally transparent section to either allow the wound or burn tobe exposed to the air to be observed visually. Additionally, the secondsection could be modified to include a mechanism for irrigating thewound or burn under the bandage so that the wound or burn could becleaned or treated without having to remove the dressing. Also, at leastone side of the second section could be designed so that it is capableof isolating the wound in a clean environment by creating a solidantiseptic barrier around the wound through the use of a colloid typeadhesive or be capable of contacting a wound or burn so that medicinecould be applied to the wound or burn directly.

With respect the features of the present invention as an epidermallifting mechanism, the epidermal lifting mechanism may be generallydescribed as comprising at least one strip of material having a firstside and a second side, the strip further including a first end portionand a second end portion. Between the first side and the second side arepreferably one or more layers of predetermined materials.

These layers of materials include without limitation, a silicone coatedrelease liner, an adhesive system to adhere the epidermal liftingmechanism to the nose, a top layer of material, and a spring mechanism.Obviously, the release liner is removed prior to placing the epidermallifting mechanism on the bridge of the nose. The adhesive system, justlike the adhesive system for the dressing mechanism, can include apressure sensitive hypoallergenic acrylic or a hydrocolloid material butany suitable adhesive system may be used. The top layer of material canbe either a non-woven material or a material with some stretchcharacteristics such as a three mil polyurethane film. The springmechanism may comprise a polyester film (usually 2 mils to 8 mils inthickness but any suitable thickness range may be used, e.g., 1-15 milswould be suitable as an alternative thickness range but any thicknessrange can be used depending upon the desired use and durability)laminated to a spun bonded polyester material. The spun bonded polyestermaterial may or may not be coated with a pressure sensitive adhesive.The spring mechanism may be a plurality of materials which are laminatedtogether.

Although unitary, the mechanism has the following components: a pair ofnose pods and a bridge section. The nose pods include an exposedadhesive surface which is bonded to the skin on the sides of the nose.The bridge section of the device has at least one fulcrum point, locatedat the bridge of the nose when it is applied to the bridge of a nose,and lies across the bridge of the nose.

However, it should also be noted that the present invention could beapplied to simply one side of the nose with the bridge section of thedevice ending at the top of the bridge of the nose and being adheredthereto. Alternatively, the bridge section could simply be a strip ofresilient or elastic material which is connected to the cheek of thewearer at one end by use of an adhesive material and the nose pod beingconnected to the side of the nasal passage at the other end.

It should be noted that it is preferable for the nose pods to includehorseshoe shaped slits or cuts which are made in the top layer of thematerial through the adhesive layer which, when applied to the nose,allows the spring action to generate a uniform lifting force in asuction cup like manner while at the same time applying a shearing forceto the adhesive itself due to the presence of the slit structures,rather than a lifting force thereby creating flexibility from the liftpoint to the adhesion point. By decreasing the lifting (peel) force onthe adhesive, the stability of the bond between the adhesive and theskin is greatly increased and allows more flexibility of the dilatorduring facial movement. Thus the dilator will stay comfortably in placeeven during vigorous movement by the wearer; even when used inapplications other than a nasal dilator. The lifting (peel) force on theadhesive may be further decreased by use of a coextensive, overlayingbarrier layer comprised of a non-adhesive material. The non-adhesive,overlaying barrier layer is preferably located between a portion of theadhesive material and the pod material such that an area ofnon-adhesiveness is created between the adhesive layer and the pod.

A pair of flaps attached adjacent to the bridge section of the epidermallifting mechanism create another pair of fulcrum points (fulcrum point2) between the bridge of the nose (fulcrum point 1) and the adhesivematerial thereby increasing the dilation force of the outer epidermis ofthe nasal passages. The additional fulcrum points are accomplished byfolding of the flaps adjacent to the bridge section underneath theepidermal lifting mechanism allowing the adhesive area of each flap toadhere to the bottom adhesive area of the bridge section of theepidermal lifting mechanism securing it in place. The flaps includeperforations for ease of folding.

As discussed above, the pair of flaps creates an additional fulcrumpoint. Further, when folded they provide a cushioned area for the bridgeof the nose to cover the adhesive on the underside of the epidermallifting mechanism so when applied for several hours and then removeddiscomfort to the skin tissue on the bridge of the nose is eliminated.

When the top and bottom spring laminates are laminated together and theepidermal lifting mechanism is applied to the nose, the bending of themulti-level springing increases the opening force to the nasal passagesover a single level spring. Adding a layer of spring material on top ofanother layer of spring material creates a leaf spring action. Becausethere is a stretching force introduced into the top layer when bent overa fulcrum point, a stronger spring action is created as compared to asingle layer spring of equal of thickness. Furthermore, bending over afulcrum point or at multiple fulcrum points further improves the springaction.

Additionally, various pod configurations may be used to allow forflexibility of the bottom spring and/or to allow the pods to conform tothe irregular surfaces of the nose or epidermal layer to which they areapplied. Further, a fulcrum point may be provided by use of two, spacedapart pad structures having elastic material there between.

A key advantage of this mechanism is that anytime a person engages inphysical activity that increases his or her heart rate, this mechanismallows for the delivery of more oxygen to the lungs. Further, themechanism allows for more air to be effectively exhaled and thus bothinhalation and exhalation are enhanced so overall breathing efficiencyis enhanced.

Alternatively, this invention may be described as a method forincreasing the flow rate of gas through the nasal passages, the methodcomprising the steps of applying the epidermal lifting mechanism bybending the spring material over the bridge of the nose so that theadhesive material of the nose pods comes into positive contact with thesides of the nose and releasing the nose pods thus allowing the springsto mechanically lift the epidermal surface of the nose and increase thesize of the nasal passage openings.

Alternatively, the present invention may be structure which may be usedas a nasal dilator wherein the nasal dilator comprises two separatepieces each capable of acting independently of the other. Each piecehaving at least one nose pod and an elastic member or strip attached tothat nose pod. The elastic member or strip having a first end and asecond end with the nose pods being attached to the first end. Theelastic member having a second end attached to an anchor mechanism. Theanchor mechanism having a first side and an adhesive material includedthereon. The nose pod having the previously described structure for anose pod. The anchor mechanism being applied to a predetermined area ona persons cheek a sufficient distance away from the side of the personsnose so that the nose pod, coupled to the elastic member, may be appliedto the outside surface or epidermis surrounding the nasal passage of apersons nose and the elastic member retracting between the anchormechanism and the nose pod causing lifting of the epidermis on the sideof the nose and thereby increasing the opening of the nasal passage way.

Accordingly, the present invention may be considered an epidermalpositioning mechanism having an elastic material coupled to a first endpiece and a second piece. The first and second end pieces each having atleast one side including an adhesive material. Preferably, but notnecessarily, depending upon the application of the present invention, atleast one of the end pieces would be the anchoring structure ormechanism while the other end piece acts as a lifting end piece.

Additionally the present invention need not solely be used as a nasaldilator but, as previously noted, may also be used as an epidermalpositioning system for treatments of wounds and incisions by eitherkeeping the wound or incision open for the purpose of medical treatmentsuch as surgical procedures or cleansing of the wound or incision or bypositioning the ends of the wound together in close proximity to aid insuturing of a wound or simply to be used as a suture mechanism in and ofitself to hold the ends of a wound together or to hold the ends of anincision together.

Further, when the device of the present invention is used over a woundit may also have application as a bandage. For example, the elastic orresilient material will have at least one side positioned over andadjacent the wound or incision area. This side positioned over oradjacent the wound or incision area may have a medicinal materialapplied thereto. This medicinal material may be, for example, zincchromate or an alginate like calcium or sodium alginate; each of thosematerials respectively having anti-bacterial and clot enhancingcapabilities. Other medicinal materials or even non-medicinal materialscould also be applied using the device of the present inventiondepending upon the goals and results desired of the particular user.

If the epidermal positioning mechanism of the present invention is usedas a bandage it should be noted that a bandage structure could becombined with the present invention such that the bandage structurewould have at least a first end and second end and elastic materialwould be coupled to the first end and to the second end with ananchoring structure coupled to a portion of the elastic material aswell. This would provide at least two anchor points at the ends of theresilient elastic material not coupled to the bandage structure. In thismanner one of the anchor structures could be adhered to the skin at apredetermined position and the bandage structure positioned over thewound or incision by stretching the resilient or elastic material andthen applying the other anchor structure could be to the skin at anotherpredetermined position. In this manner, the elastic material willcontract and this will have the effect of forcing the bandage materialinto more positive contact with the wound and thereby enhance theeffectiveness of the bandaged material. If desired a medicinal compoundcould be applied to the surface of the bandage material which isadjacent to the surface of the wound or incision. Additionally, thebandage material may be comprised of a hydrophilic material.

The anchoring structure in such a use would of course comprise at leasttwo end pieces coupled to the elastic material at predeterminedpositions and the end pieces would include an adhesive material attachedto a side of the anchoring end pieces adjacent to the epidermis or skinto which they are to be attached. The bandage structure could also havea medicinal material applied to it as previously noted with respect tothe elastic material. The adhesive material may extend as an adhesivelayer coextensive a side of the anchoring end pieces, or alternatively,may extend over a predetermined portion of a side of an anchoring endpiece. As discussed with regard to a previous embodiment, a coextensive,overlaying barrier layer composed of a non-adhesive material may beprovided. The non-adhesive overlaying barrier layer is preferablylocated between a portion of the adhesive material and end piecematerial.

Additionally, the mechanism of the present invention could be describedas epidermal lifting mechanism having anchor/lifting portions, connectedvia an elastic or stretchable material, and include an adhesive surface.The anchor/lifting portions being such that each portion, depending uponwhere it is applied, may act as either an anchor portion or a liftingportion. The anchor/lifting portions having a plurality of incisions orcuts of predetermined shape which divide each anchor/lifting portioninto a plurality of adhesive areas. This division of the anchor/liftingportion into a plurality of adhesive areas allows the anchor/liftingportion adhesive areas to be divided such that after a firstanchor/lifting portion is applied to the desired epidermal location afirst predetermined portion of that first anchor/lifting mechanism maybe peeled away and leave a second predetermined portion, having apredetermined shape due to the plurality of cuts or incisions, in placeon the epidermal location. Subsequently, a second anchor/liftingportion, connected to the first anchor/lifting portion via the elasticmaterial, may be applied to a second predetermined or desired epidermallocation so that the elastic material is stretched a desired amount. Thesecond anchor/lifting portion, if it is substantially similar to thefirst anchor/lifting portion may be applied to the epidermis so that itmay be peeled away and leave a second predetermined portion, having apredetermined shape due to the plurality of cuts or incisions, in placeon the epidermal location. Accordingly, the first and secondanchor/lifting portions may act as a separate anchor point and liftingpoint or as separate anchor points or as separate lifting points and theelastic material may simply be used to supply tension between the pointsor it may be used to apply a material such as a medicine to theepidermis located between the two points or it may be used to supplytension and apply a material between the two points, etc.

It is to be understood that it is within the scope of this invention toprovide hook and loop type fastening means for the devices described.The hook and loop type fastener means may be used in combination withadhesive or as the sole means of applying a device to a limb, by way ofexample.

Further, the present invention may be described as a method for using adressing mechanism where the dressing mechanism comprises a firstsection, a second section, and a third section; the first section beingcoupled to the second section and the second section being coupled tothe third section; the first section and the third section comprising anelastic material; the first section and the third section each having afirst side; and a predetermined portion of the first side including anadhesive located thereon. The method consequently comprising: First,applying the first section to a first predetermined location on anepidermis. Second, pulling the third section toward a secondpredetermined location on the epidermis. Third, applying the thirdsection to the second predetermined location on the epidermis.

Alternatively, the method could be described as a method for using adressing comprising a plurality of anchor structures, a treatmentsection, and an elastic material. The elastic material extending fromthe anchoring structure to the treatment section. The elastic materialbeing coupled to at least one anchoring structure at a first couplingsection and to the treatment section at a second coupling section. Themethod comprising the steps of positioning the treatment section over afirst predetermined area of an epidermis; applying at least one anchorstructure to a second predetermined area of the epidermis; and applyingat one other anchor structure to a third predetermined area of theepidermis.

DESCRIPTION OF THE DRAWINGS

FIG. 1 is a top plan view of a prior art nasal strip.

FIG. 1A is a top plan view of the prior art nasal strip of FIG. 1including the flaps of the present invention.

FIG. 2 is a side elevational view of a relaxed multi-level spring.

FIG. 3 is a side elevational view of a tensioned multi-leveled springbent over a fulcrum point.

FIG. 4 is a side elevational view of the epidermal lifting mechanismshowing its layered components.

FIG. 5 is a schematic side elevational view of the epidermal liftingmechanism wherein the arrows depict the sheer force and peeling forces.

FIG. 6 is a top plan view of an end portion of the epidermal liftingmechanism.

FIG. 7 is a bottom plan view of the epidermal lifting mechanism.

FIG. 8 is a side elevational view depicting the primary layers of theepidermal lifting mechanism.

FIG. 9 is a top plan view of an alternative embodiment of the epidermallifting mechanism.

FIG. 10 is a top plan view of an alternative embodiment of the epidermallifting mechanism.

FIG. 11 is a top plan view of an alternative embodiment of the epidermallifting mechanism.

FIG. 12 is a top plan view of an alternative embodiment of the epidermallifting mechanism.

FIG. 13 is a top plan view of an alternative embodiment of the epidermallifting mechanism.

FIG. 14 is a top plan view of an alternative embodiment of the epidermallifting mechanism.

FIG. 15 is a side elevational view showing the epidermal liftingmechanism properly positioned on the bridge of the nose.

FIG. 16 is a side elevational view showing the epidermal liftingmechanism improperly positioned too high on the bridge of the nose.

FIG. 17 is a side elevational view showing the epidermal liftingmechanism improperly positioned too low on the bridge of the nose.

FIG. 18 is an exploded view of the preferred embodiment of the presentinvention.

FIG. 19 is a top plan view of an alternative embodiment of the presentinvention including an elastic strip.

FIG. 20 is a top plan view of an alternative embodiment of the presentinvention showing an embodiment having application for only one side ofa persons nose or for raising a predetermined portion of an epidermallayer.

FIG. 21 is a top plan view of an alternative embodiment of the presentinvention showing the elastic member having a first end coupled to a podand a second end coupled to an anchor mechanism for application to aselected area of a person or animal epidermis. For example, the anchormechanism could be applied to a person's cheek and the pod applied tothe epidermis of a persons nose to enhance opening of the nasal passage.

FIG. 22 is a side elevational view illustrating embodiment of FIG. 21with the anchor mechanism applied to a person's cheek and the podapplied to a side of a persons nose.

FIG. 23 top plan view which illustrates the embodiment of FIG. 21 in useto hold an incision open.

FIG. 24 top plan view which illustrates the embodiment of FIG. 19 in useto keep an incision closed.

FIG. 25 top plan view which illustrates the embodiment FIG. 19 in use tokeep an incision closed with the ends of the incision kept in properalignment to add in suturing the incision.

FIG. 26 is a side elevational view showing the embodiment of either FIG.21 or FIG. 19 being used on persons nose as a nasal dilator to enhancebreathing. The embodiment of FIG. 19 is believed to be preferable to theembodiment of FIG. 21 for this purpose although either could be used.

FIG. 27 is a perspective view generally showing a human nose.

FIG. 28 is a cross sectional view of the nose in FIG. 27 with the noseshown absent any nasal dilator.

FIG. 29 is a cross sectional view of the nose in FIG. 27 with the noseshown being in a state of relatively little air flow through the nasalpassages.

FIG. 30 is a cross sectional view of the nose in FIG. 27 with a nasaldilator of the present invention applied illustrating an appreciable airflow through the nasal passages.

FIG. 31 is a top plan view of another alternative embodiment of theproposed invention.

FIG. 32 is a top plan view of an additional proposed embodiment of thepresent invention shown as the embodiment would be manufactured andillustrating the area that is removed to expose the adhesive and thenbent backwards and applied as shown in FIG. 33.

FIG. 33 is a top plan view of the embodiment shown in FIG. 32 applied toan epidermal surface and illustrating the shear point, the adhesive, andthe elastic or stretchable material.

FIG. 34 is a top plan view of an alternative structure to the embodimentillustrated in FIG. 19.

FIG. 35 is a perspective view of an another alternative structure of thepresent invention.

FIG. 36 is a top plan view of the embodiment disclosed in FIG. 35.

FIG. 37 is a perspective view of an another alternative structure of thepresent invention.

FIG. 38 is a top plan view of the embodiment disclosed in FIG. 37.

FIG. 39 is a perspective view of an another alternative structure of thepresent invention.

FIG. 40 is a top plan view of the embodiment disclosed in FIG. 39.

FIG. 41 is a top plan view another embodiment of the present inventionillustrating an embodiment of the present invention by supper-imposingtwo views of the embodiment; the phantom lines showing the embodiment atrest without the latex sections being stretched and the solid linesillustrating the latex sections being stretched while the center orsecond section maintains position over the treatment area despite theuneven tension applied to the various anchor sections.

FIG. 42 is a top plan view of the embodiment shown in FIG. 41illustrating how the second center section may be positioned and variousanchoring sections positioned to adjust the stress or pressure appliedat the center section.

FIG. 43 is a perspective view of another embodiment of the presentinvention.

FIG. 44 is a top plan view of the embodiment disclosed in FIG. 43.

FIG. 45 is a perspective view of an another alternative structure of thepresent invention.

FIG. 46 is a top plan view of the embodiment disclosed in FIG. 45.

FIG. 47 is a top plan view illustrating how force may be distributed intwo directions in a particular embodiment of the present invention.

FIG. 48 is a top plan view illustrating how force may be distributed infour directions in a particular embodiment of the present invention.

FIG. 49 is a perspective view of an another alternative structure of thepresent invention.

FIG. 50 is a top plan view of the structure disclosed in FIG. 49.

FIG. 51 is a perspective view of an another alternative structure of thepresent invention.

FIG. 52 is a top plan view of the structure disclosed in FIG. 51.

FIG. 53 is a perspective view of an another alternative structure of thepresent invention.

FIG. 54 is a top plan view of the an alternative embodiment to thestructure disclosed in FIG. 53.

FIG. 55 is a perspective view of an another alternative structure of thepresent invention.

FIG. 56 is a top plan view of an alternative embodiment of thealternative structure shown in FIG. 55.

FIG. 57 is a top plan view showing the structure disclosed in FIG. 55applied over the incision of a wound and acting as a guide for suturingthe wound.

FIG. 58 is a top plan view showing the two of the structures disclosedin FIG. 55 being used to hold a wound open.

FIG. 59 is a perspective view showing the structure disclosed in FIG. 55being used for guiding an intravenous tube and holding the tube in apredetermined position.

FIG. 60 is a top plan view showing the structure disclosed in FIG. 55holding the edges of a wound or incision together.

FIG. 61 is a perspective view of an another alternative structure of thepresent invention.

FIG. 62 is a top plan view of the structure disclosed in FIG. 61.

FIG. 63 is a perspective view of an another alternative structure of thepresent invention.

FIG. 64 is a top plan view of the structure disclosed in FIG. 63.

FIG. 65 is a perspective view of an another alternative structure of thepresent invention.

FIG. 66 is a top plan view of the structure disclosed in FIG. 65.

FIG. 67 is a perspective view of an another alternative structure of thepresent invention.

FIG. 68 is a view from line 68—68 of FIG. 69.

FIG. 69 is a top plan view of the structure disclosed in FIG. 67.

FIG. 70 is a perspective view of an another alternative structure of thepresent invention.

FIG. 71 is a top plan view of the structure disclosed in FIG. 70.

FIG. 72 is a perspective view of an another alternative structure of thepresent invention.

FIG. 73 is a top plan view of the structure disclosed in FIG. 74.

FIG. 74 is a top plan view of another alternative embodiment of thepresent invention.

FIG. 75 is a perspective view of an another alternative structure of thepresent invention.

FIG. 76 is a top plan view of the structure disclosed in FIG. 75.

FIG. 77 is a cross-sectional view from line 77—77 of FIG. 84.

FIG. 78 is a cross-sectional view from line 78—78 of FIG. 86.

FIG. 79 is a cross-sectional view from line 79—79 of FIG. 86.

FIG. 80 is a cross-sectional view of a structure similar to thestructure disclosed in FIG. 86 illustrating the use of input and outputports which may be used to irrigate a wound or deliver medicine to apredetermined area.

FIG. 81 is a view taken from line 81—81 of FIG. 39.

FIG. 82 is a view taken from line 82—82 of FIG. 40

FIG. 83 is a top plan view of another alternative embodiment of thepresent invention.

FIG. 84 is a perspective view of the alternative structure of thepresent invention disclosed in FIG. 83.

FIG. 85 is a top plan view of another alternative embodiment of thepresent invention.

FIG. 86 is a perspective view of the alternative structure of thepresent invention disclosed in FIG. 85.

FIG. 87 is a top plan view of another alternative embodiment of thepresent invention.

FIG. 88 is a top plan view of another alternative embodiment of thepresent invention.

FIG. 89 is an illustration showing how the embodiment disclosed in FIG.70 may be used on an area of the human body that is subject to a highdegree of movement.

FIG. 90 is an illustration showing how another alternative embodiment ofthe present invention may be used on an area of the human body that issubject to a high degree of movement.

FIG. 91 illustrates how another alternative embodiment of the presentinvention may be used as a nasal dilator.

FIG. 92 illustrates another method by which the alternative embodimentof the present invention shown in FIG. 91 may be used as a nasaldilator.

FIG. 93 illustrates how the embodiment shown in FIG. 91 may be used tohold a flap of skin, in this case a human ear flap, in a predeterminedposition. This is useful where its is desired to have easy access to anarea that might otherwise be blocked by a fold or flap of skin thusmaking work on that area difficult or cumbersome.

FIG. 94 is a perspective view of one embodiment of the presentinvention, and illustrating a hydrophilic pad material.

FIG. 95 is a top plan view of the device illustrated in FIG. 94.

FIG. 96 is a cross sectional view of the device shown in FIGS. 94 and 95and taken along line 96—96 of FIG. 95.

FIG. 97 is a perspective view of a device similar to that of FIGS.94-96, but showing a hook and loop type fastener in combination withadhesive fastening means.

FIG. 98 is a top plan view of the device illustrated in FIG. 97.

FIG. 99 is a cross sectional view of the device shown in FIGS. 97-98,and taken along line 99—99 of FIG. 98.

FIG. 100 illustrates the device shown in FIGS. 97-99 in use around ahuman limb.

FIG. 101 is a top plan view of a device similar to that shown in FIGS.97-100, but showing use of a hook and loop type fastener absent theadditional adhesive attachment means illustrated in previous views.

FIG. 102 is a cross sectional view of the device shown in FIG. 101 andtaken along line 102—102 thereof.

FIG. 103 is a top plan view of an embodiment showing a barrier layer.

FIG. 104 is a cross sectional view of the device shown in FIG. 103 andtaken along line 104—104 thereof.

FIG. 105 is a perspective view of another embodiment including a barrierlayer.

FIG. 106 is a cross sectional view of the device seen in FIG. 105 andtaken along line 106—106 thereof.

FIG. 107 is a top plan view of another embodiment including a barrierlayer.

FIG. 108 is a cross sectional view of the device seen in FIG. 107 andtaken along line 108—108 thereof.

FIG. 109 is a top plan view of another embodiment including a barrierlayer.

FIG. 110 is a cross sectional view of the device seen in FIG. 109 andtaken along line 110—110 thereof.

FIG. 111 is an exploded view of one embodiment of the present inventionand showing a plurality of barrier layers.

FIG. 112 is a perspective view of the embodiment seen in FIG. 111 inplace on an epidermis.

FIG. 113 is a view similar to that of FIG. 112, but showing the devicein an arched position to more clearly show the barrier strip.

DETAILED DESCRIPTION

Although the disclosure hereof is detailed and exact to enable thoseskilled in the art to practice the invention, the physical embodimentsherein disclosed merely exemplify the invention which may be embodied inother specific structure. While the preferred embodiment has beendescribed, the details may be changed without departing from theinvention, which is defined by the claims.

The invention comprises an epidermal lifting mechanism for providing alifting force to a predetermined epidermal area, such as the bridge ofthe nose, to provide an increased flow rate of gas through the nasalpassage and will be referred to generally as 10 in the followingdetailed description.

Referring to FIGS. 1 and 1A, a prior art device is shown. The prior artdevice shown in FIG. 1 is currently marketed by CNS, Inc. of Chanhassen,Minn. and sold under the trademark BREATHE RIGHT. The same device isshown in FIG. 1A, however the device in FIG. 1A includes the flaps ofthe present invention whose structure and advantages are discussed indetail below.

The present invention, indicated generally by the reference numeral 10,includes a two part multi-level leaf spring 20 as shown in FIG. 2. Thetwo part multi-level leaf spring 20 comprises a pair of spring laminates22 and 24. Each spring laminate 22 and 24 is manufactured from a 2 milto 8 mil polyester film laminated to a spun bonded polyester material.The spun bonded polyester material may or may not be coated with apressure sensitive adhesive. The spring laminates 22 and 24 arelaminated together.

As illustrated in FIG. 3, when the top 24 and bottom 22 spring laminatesare laminated together and the invention 10 is applied to the bridge ofthe nose, represented by the fulcrum point 26, the bending of themulti-level spring 20 increases the opening force to the nasal passagesover a single level spring.

Adding a layer of spring material 24 on top of another layer 22 ofspring material creates a leaf spring action. Because there is astretching force introduced into the top layer 24 when bent over afulcrum point, a stronger (compound) spring action is created ascompared to a single layer spring of equal thickness. Furthermore,bending over a fulcrum point creates a stronger yet spring action.

Now referring to FIGS. 4 and 18, the material layers of the invention 10include a silicone coated release liner 30, an adhesive system 40 toadhere the epidermal lifting mechanism 10 to the nose, a top layer ofmaterial 50, and the two part spring laminate 20. The top layer 50 iscomposed of two layers of material 50A and 50B and contains the springs24 and 22 there between, as shown in FIG. 18. The release liner 30 isremoved prior to placing the mechanism 10 on the bridge of the nose. Theadhesive system 40 can either be a pressure sensitive hypo-allergenicacrylic or a hydrocolloid system. The top layer of material 50 can beeither a non-woven material or a material with some stretchcharacteristics such as a 3 mil polyurethane film.

The preferred embodiment of the invention 10 is shown in FIG. 7.Although unitary in construction, it has the following components: apair of pods 60 and a bridge section 70. The pods 60 include an exposedadhesive surface 62 which is bonded to the skin on the sides of thenose. The pod 60 configurations allow for flexibility of the bottomspring 22 to conform to the irregular surfaces of the nose. The bridgesection 70 of the device has at least one fulcrum point as shown in FIG.3 and lies across the bridge of the nose as shown in FIG. 15.

As shown in FIG. 6, the pods 60 include horseshoe shaped cuts orincisions 64 in the top layer of material 50 through the adhesive layer40 which, when applied to the nose, allows the spring action to generatea uniform lifting force in a suction cuplike manner while at the sametime applies a shearing force to the adhesive itself rather than apeeling force thereby creating flexibility from the lift point to theadhesion point. This principle is demonstrated in FIG. 5. By decreasingthe peel force 42 on the adhesive 40 the bond between the adhesive 40and the skin is greatly increased and allows more flexibility of theepidermal lifting mechanism 10 during facial movement. The shearingforces are shown at 44.

Referring back to FIG. 7, the present invention 10 may be furtherimproved by including a pair of flaps 80 which are attached adjacent tothe bridge section 70 of the invention 10. The flaps 80, when foldedunderneath or over the adhesive layer 40 of the bridge section 70,create another pair of fulcrum points along lines 82 between the bridgeof the nose (fulcrum point 2) and the pods 60 when the invention 10 isapplied to the wearer's nose. Thus, the flaps 80, when folded, functionto increase the dilation force to the outer epidermis of the nasalpassages.

More specifically, the additional fulcrum points 82 are accomplished byfolding the flaps 80 underneath the bridge section 70 thereby allowingthe adhesive area of each flap 84 to adhere to the bottom of the bridgesection 70 thus securing it in place. The flaps 80 further includeperforations 86 for ease of folding.

As discussed above, the pair of flaps 80 adds fulcrum points.Accordingly, when the flaps 80 are folded they form end sections alonglines 82 which will be located to either side of the bridge of the nose.Each of the end sections along lines 82 will act as a fulcrum point inaddition to the bridge of the nose thereby increasing the number offulcrum points and the mechanical lifting ability of the presentinvention. Further, when folded they provide a cushioned area for thebridge of the nose and cover the adhesive 40 on the underside of thebridge section 70 so when applied for several hours and then removed,discomfort to the skin tissue on the bridge of the nose is greatlyreduced or eliminated since no adhesive has been in contact with thebridge of the nose due to the barrier created by the flaps.

The material layers of the invention 10 are shown in FIG. 8. Again, thelayers include a silicone coated release liner 30, an adhesive system 40to adhere the epidermal lifting mechanism 10 to the nose, a first springlaminate 22, a second spring laminate 24, and a top layer of material50.

Alternative embodiments of the invention 10 are shown in FIGS. 9 through14. In FIG. 9, the shape of the pods 60 is shown to be rectangularinstead of round. In FIG. 10, the horseshoe shaped cuts or incisions 64have been removed and additional slits 66 and 66A have been added. Inthis embodiment, when the flaps 80 are not folded over, slits 66Amechanically adjust the peeling action to a shear action therebyallowing greater adhesion over the predetermined epidermal area.Additionally, in this embodiment a cut could be made along line 100 todivide the invention 10 into sections 13 and 15 whereby section 13 couldbe discarded and section 15 could be used as a dilator for only one sideof a person's nose.

The embodiment shown in FIG. 11 includes slits 66 and further includes atwo-part pod 60. Pod 60 comprises an upper pod half 68 and a Lower podhalf 69. Pod halves 68 and 69 and slits 66 allow for greater flexibilityof the pod 60 on the nose of the wearer.

The embodiment shown in FIG. 12 is similar to that shown in FIG. 10 withthe exception that the bridge section 70 has been widened. Theembodiment of FIG. 13 includes the wider bridge section 70 incombination with rectangular pods 60. Additional slits 67 have also beenadded near the outer sides of the pods 60. Slits 67 change the directionof the force applied to the pods 60 so that instead of a peel force (aforce which tends to peel away the pods 60 from the epidermis to whichthey are applied) to a sheer forces (a force which tends to drag thepods 60 across the epidermis to which they are applied).

The embodiment depicted in FIG. 14 demonstrates the principal thatdifferent pod 60 configurations can be used on the same epidermallifting mechanism 10. The pod 60 shown on the left side has a slopingside to allow for better adhesion to the side of the nose.

The application of the invention 10 to the nose of the wearer is shownin FIGS. 15 through 17. Preferred installation of the epidermal liftingmechanism 10 on the bridge of the nose is shown in FIG. 15 while in FIG.16, the epidermal lifting mechanism 10 is applied too high on the noseand is applied too low in FIG. 17. However, while the positions shown inFIGS. 16 and 17 are not preferred they are functional since thestructure of the present invention 10 allows a user the ability to applythe invention 10 over a relatively large epidermal area and thuseffectiveness of the present invention is greatly enhanced. The presentinvention will generally work effectively in all the positions shown inFIGS. 15-17.

Alternatively, this invention 10 may be described as a method forincreasing the flow rate of gas through the nasal passages, the methodcomprising the steps of removing the release liner 30, and positioningthe invention 10 as shown in FIG. 15 or as shown in FIGS. 16 and 17,depending upon the comfort of the wearer.

Referring now to FIG. 19, a top plan view of an alternative embodimentof the present invention 10 may be seen to comprise an elasticmidsection 110 having ends 111 and 112. Ends 111 and 112 are coupled topod sections 60. This embodiment does not include any spring mechanismother than the elastic section 110; the elastic section 110 taking theplace of the spring mechanism. The resiliency of the elastic section 110will cause the two nasal pods 60 to be drawn together when the elasticmember contracts. If this is done over a fulcrum point such as thebridge of the nose it will cause a lifting of the nasal passages andthus may be used as a nasal dilator as illustrated in FIG. 26.

Additionally the mechanism of FIG. 19 may be used as shown in FIGS. 24and 25 to aid in holding a wound or incision 17 closed either for thepurposes of healing as illustrated in FIG. 24 or for the purpose ofaiding in suturing as illustrated in FIG. 25. The pods 60 adhering tothe epidermis to either side of the wound and the elastic member 110being stretched across the wound so that it will contract and draw thetwo pods 60 towards each other thereby closing the wound in an effectivemanner. Additionally, when the wound is closed in this manner a surgeonor physician may have both hands free to apply sutures 115 along thewound or incision 17. This is believed particularly helpful when dealingwith a large wound or incision.

With respect to the embodiment of the invention shown in FIG. 19 itshould be noted that U shaped cuts or incisions 64 are also illustrated.Again, these cuts or incisions may be of any shape although the U, orhorseshoe shape is preferred, however the embodiment disclosed in FIG.19 could function with these U, or horseshoe shaped cuts or incisions64.

Referring now to FIG. 20 an alternative embodiment of the presentinvention for use as a nasal dilator is shown. In this embodiment thespring sections are included as shown in FIG. 18 although they are notshown in FIG. 20. This embodiment functions in a manner similar to theembodiment FIG. 10 and is simply meant to illustrate once again that thenasal dilator of the present invention could be applied to only one sideof a person's nose 19.

Referring now to FIG. 21 another alternative embodiment of the presentinvention is shown in a top plan view illustrating the elastic member110 coupled at its end 112 to pod 60 and coupled at its end 111 to ananchor 120. The anchor 120 has an adhesive layer applied to it in thesame manner as the adhesive layer which is applied to the pod 60. Theembodiment of the invention 10 shown in FIG. 21 has application formaintaining an incision opening or wound opening for either a surgicalprocedure or cleansing purposes as illustrated in FIG. 23 or for use asa nasal dilator for application to only side of a person's nose asillustrated in FIG. 22.

Referring to FIG. 22 pod 60 may be seen applied to the side of a personsnose 19 and elastic member 110 is stretched so that anchor 120 may beapplied to the side of persons face 19A. Thus, elastic member 110 willcontract and pull pod 60 and anchor 120 toward one another but sinceanchor 120 is positioned on a substantially stationary epidermal area ofthe person's face the majority of the movement will occur at pod 60causing the epidermal area to which it is applied to be pulled outwardand thus open the nasal passage.

Referring to FIG. 23, the incision 17 may be seen to be held open by theaction of the embodiment disclosed in FIG. 21. The anchors 120 areapplied to a substantially stationary epidermal area and the elasticmembers 110 are stretched and the pods 60 are positioned to either sideof the wound or incision to hold it open so that the wound may becleansed or a surgical procedure may be performed through the incisionthus freeing the physician's hands for this purpose.

It should be noted that the U shaped cuts 64 are disclosed in theembodiment of the present invention 10 shown in FIG. 21. While these Ushaped cuts are preferred they are not considered necessary to practicethe present invention.

Referring now to FIGS. 28, 29 and 30, FIG. 28 shows the nose 19 and thenasal passages 119 in cross sectional view. The nasal passages in FIG.28 being shown open but absent the use of any nasal dilator. In FIG. 29the same cross sectional view is shown but the nose 19 and in particularthe nasal passages 119 are shown being in a state of relatively littleairflow through the nasal passages 119. FIG. 30 illustrates a crosssectional view using a nasal dilator of the present invention 10 whereinthe nasal passages 119 of the nose 19 are held substantially open forairflow through the nasal passages 119.

Clearly, the alternative embodiments shown in FIGS. 19 and 21 could alsobe practiced according to the methods previously disclosed.Specifically, the embodiment of FIG. 19 could be practiced as a methodusing the structure previously described wherein the embodimentdisclosed in FIG. 19 is applied by first applying one nose pod section60 to ore side of a wound 17 and stretching the elastic member 110 overthe wound 17 and then applying the nose pod section 60 to the other sideor opposite side of the wound or incision 17 whereby the wound orincision 17 is held closed. Additionally, it should be noted that amedicinal material could be applied to the elastic member 110 over theportion of its surface which would be adjacent to the wound or incision17 and thus aid in healing of the wound. Medicinal materials such aszinc chromate or calcium alginate or sodium alginate are possible suchcompounds.

Alternatively, the embodiment of FIG. 21 could be used in a methodwherein the pod 60 is applied to an epidermal area which is desired tobe pulled or raised. This epidermal area could be an area immediatelyadjacent an incision or wound 17 or the side epidermis of a person'snose 19. The elastic member 110 being stretched and the anchor portion120 being applied with its adhesive side to an epidermal area which isrelatively stationary and the elastic material 110 contracting andthereby raising or pulling or lifting the skin to which the pod 60 hasbeen attached to via its adhesive side.

Alternatively, as illustrated in FIGS. 31, 32, and 33, the mechanism ofthe present invention could be described as epidermal lifting mechanismhaving anchor/lifting portions 120, connected via an elastic orstretchable material 110, and include an adhesive surface 121. Theanchor/lifting portions 120 being such that each portion 120, dependingupon where it is applied, may act as either an anchor portion 120 or alifting portion 120. The anchor/lifting portions 120 having a pluralityof incisions or cuts 64 of predetermined shape, (e.g., U shaped asillustrated in FIGS. 31-33) which divide each anchor/lifting portion 120into a plurality of adhesive areas 121 a and 121 b. This division of theanchor/lifting portion 120 into a plurality of adhesive areas 121 allowsthe anchor/lifting portion adhesive areas 121 to be divided such thatafter a first anchor/lifting portion 123 is applied to the desiredepidermal location a first predetermined portion 121 c of that firstanchor/lifting portion 120 may be peeled away and leave a secondpredetermined portion 121 d, having a predetermined shape due to theplurality of cuts or incisions 64, in place on the epidermal location.Subsequently, a second anchor/lifting portion 125, connected to thefirst anchor/lifting portion 123 via the elastic material 110, may beapplied to a second predetermined or desired epidermal location so thatthe elastic material 110 is stretched a desired amount. The secondanchor/lifting portion 125, if it is substantially similar to the firstanchor/lifting portion 123 may be applied to the epidermis so that itmay be peeled away and leave a second predetermined portion 121 d,having a predetermined shape due to the plurality of cuts or incisions64, in place on the epidermal location. Accordingly, the first andsecond anchor/lifting portions 123 and 125 may act as a separate anchorpoint and lifting point or as separate anchor points or as separatelifting points and the elastic material 110 may simply be used to supplytension between the points 123 and 125 or it may be used to apply amaterial such as a medicine to the epidermis located between the twopoints or it may be used to supply tension and apply a material betweenthe two points, etc. The purpose of this alternative embodiment to takeadvantage of the multiple shear points 200 created using this design toenhance the adhesion of this embodiment to the desired epidermallocation so that the anchor/lifting portions 120 maintain properadhesion at their desired locations.

Referring now to FIGS. 35 and 36 another alternative embodiment of thepresent invention may be observed. The dressing structure 300 iscomprised of a multiple layer or laminated material 302 at its anchorsections 301 and 303 and a latex rubber 321 at its center section 325.The laminated material includes a top surface 315 made of TYVEC brandmaterial and a bottom surface 319 also made of the same material butcoated with a hypo-allergenic acrylic adhesive 327 and covered with asilicone release liner. The anchor sections 301 and 303 have an adhesivebottom layer 311 for adhering to an epidermis 11. The laminated material302 has a channel or slit: 313 into which margins 317 of the latexrubber 321 are engaged. The margins 317 include openings 304 and thechannel 313 includes the adhesive 327 which extends through the openings304 from the bottom 319 to the top 315. This creates a series ofadhesive openings 304 which act as plugs which extend through theopenings 304 and couple the upper layer 315 to the lower layer 319effectively holding the non-elastic TYVEC material together so that thelatex material 321 is effectively locked into the channel 313 and cannoteasily be removed by tension when stretched. Accordingly, margins 317are secured to the anchor sections 301 and 303 at locking section 317 a.

Still referring to FIG. 35 and FIG. 36 the center section 325 may beobserved to include a TYVEC brand material stabilizing section 323 whichis bonded to a gauze pad 314 via openings 316, in the latex 321 whichcontain adhesive 327. The adhesive 327 extending in a plug like mannerfrom the pad 314 to the stabilizing section 323. This creates a bandageor dressing structure which is suspended by the latex 321 between theanchoring sections 301 and 303. Further, as illustrated by FIGS. 51 and52 the shape of the TYVEC top layer 323 need not be rectangular but canbe of any design, e.g., round. When this embodiment is applied over awound or other predetermined area of the epidermis 11 the latex material321 is stretched between the two anchoring sections 301 and 303 whichcauses the latex 321 to act much like a leaf spring and apply a positivepressure downward through the pad 314. Accordingly, the wound to whichthis device 300 is applied will have a positive pressure against it. Itis well known in first aid that pressure applied to a wound will helpreduce bleeding. The present invention thus provides an effectivebandage which will also effectively limit bleeding from the wound.Further, the positive down pressure will effectively maintain contact ofthe pad 314 with the wound or other predetermined area despite movementof the surrounding epidermis 11.

Still referring to FIGS. 35 and 36 it should be noted that stabilitystrips 310 are included to illustrate that it is presently believed thatin commercial utilization of the present invention that it is believedto be desirable to provide material to keep the dressing structure 300relatively rigid prior to use. The strips 310 are removed prior to useby tearing the material 302 along the perforations 308. The strips 310are separated from the latex 321 by gap 318. Also, shown in FIG. 36 iscurve 320 which is believed to provide strain relief when the presentdressing structure 300 is applied so that even pressure is exertedacross the latex 321.

The openings 312, also shown in FIGS. 37 and 38, should also be noted.The openings 312 are located in a tension adjustment section 412 of thelatex 321. Depending upon the number of openings 312 or whether they arepresent at all the tension applied to the latex section 321. Further, asthe tension adjustment section 412 of the latex 321 is stretched toapply the dressing structure 300 the openings 312 will become distorted.The greater the stretching the greater the tension applied to the latexsection 321. Consequently, a person applying the dressing structuredisclosed herein may visually see the amount of tension applied to thelatex section 321. This allows a person applying a dressing 300 orseries of dressings 300 to apply the dressings 300 in a manner so thatthe pressure and exerted by the stretching of the latex 321 is keptrelatively constant. Alternatively, it allows the user to applydressings 300 which will apply a variety of pressures across the desiredtreatment area.

Referring to FIGS. 37 and 38 an alternative embodiment from that shownin FIGS. 35 and 36 may be seen wherein the pad 314 and inelasticmaterial 323 are not incorporated so that only an elastic section 322remains.

Referring to FIGS. 41 and 42, and FIGS. 45 and 46, another alternativeembodiment to the present invention is illustrated. This embodiment issubstantially the same structurally as the embodiments disclosed inFIGS. 35 and 36 with the exception that two additional anchors sections305 and 307 have been added. Also, the stabilizing section 323 is roundrather than rectangular in shape. The pad 314 is coupled to thestabilizing section as previously described. FIGS. 40 and 41 illustratethat tension adjustment sections 412 need not all apply the same levelof tension or be stretched equally. Further, the anchor sections 301,303, 305, and 307 may be moved relative to each other while the centersection 325 is maintained in position over the desired treatment area.Accordingly, when the present invention is applied over an area of thebody that is subject to movement such as an elbow, knee, or hand thecenter section 325 will maintain its position over the wound or area towhich it is desired to apply treatment.

Referring to FIGS. 39 and 40 another alternative embodiment may beobserved. In this alternative the openings 312 have been eliminated toillustrate that they are optional and not necessary structures topractice the present invention.

Additionally, the stabilizing section disclosed in FIG. 40 may be seenin FIG. 82 to be composed of a top layer 323 of TYVEC brand material, alayer of adhesive 327, a layer of latex 321 having openings 304, and apad 314 to which an ointment 390 has been applied. The pad 314 beingcoupled to the material 323 via the adhesive 327 which extends throughthe openings 304 in the latex 321.

The stabilizing section disclosed in FIG. 39 may be seen in FIG. 81 tobe composed of a top layer 323 of TYVEC brand material, a layer ofadhesive 327, a layer of latex 321 having openings 304, and a pad 314.The pad 314 being coupled to the material 323 via the adhesive 327 whichextends through the openings 304 in the latex 321.

Referring to FIGS. 43 and 44 another alternative embodiment of thepresent invention may be seen. In this embodiment four anchor sectionsare again shown coupled via respective locking sections 317 a. In thisembodiment just a latex material 321 extends between the anchor sections301,303,305, and 307. A curvature 330 is provided in the latex material321 to allow for uniform stretching of the material. Also, a perforation308 is provided to connect the anchor sections 303,305,307 and 301 toeach other prior to use of the dressing 300. The perforations are brokenwhen it is desired to use this embodiment of the dressing 300.

Referring to FIGS. 47 and 48 it is again illustrated that the latexsection 321 of the dressing 300 may be stretched or extended in aplurality of directions. This allows for versatility of use on a varietyof surfaces.

Referring to FIGS. 49 and 50 another alternative embodiment of thepresent invention is disclosed showing that the openings 312 may bedeleted from the tensioning section 312 a if desired without detractingfrom the principles of the invention disclosed herein.

Referring to FIG. 53 a very simple version of the present invention isillustrated. In this embodiment the dressing 300 is composed of a pieceof latex 321 having two ends to which anchors 301 and 303 arerespectively attached using an adhesive. The ends of the latex 321 aresimply sandwiched between the layers 315 and 319. A piece of stiffeningmaterial 323 is glued across the mid-section of the latex 321 and pad314 is glued to the underside of the latex 321 as illustrated. Thebottom side of each respective anchor section 301 and 303 having anadhesive 327 applied thereto.

Referring to FIG. 54 illustrates the embodiment of FIG. 53 with theaddition of a series of openings 383 being applied to the entiredressing 300. Depending upon the material through which the opening 383is made the function of the opening will vary. Openings 312 in the latex321 will act to vary the elasticity of the latex. Openings 383 a willcreate stress points and help maintain the dressing 300 in a straightalignment between its anchors 301 and 303. Openings 383 b will allow airaccess to the treatment area.

Referring now to FIGS. 55, 56, 57, 58, 59, and 60 another embodiment ofthe dressing 300, similar to the embodiment disclosed in FIGS. 37 and 38is disclosed. In this embodiment the entire latex section 321 isessentially comprised of tensioning section 412 having openings 312. Theanchors 301 and 303 function as previously described. The latex 321 inFIG. 55 is held in place as described in FIG. 53 while the latex 321 inFIG. 56 is held in place as described in reference to FIGS. 35 and 36 byadhesive 327 extending through openings 304. FIGS. 57-60 illustrate thatthis embodiment may be placed over an incision 17 to act as a guided forapplying stitches 17 a, see FIG. 57, or embodiments may be placed toeither side of an incision 17 to hold the incision open, see FIG. 58, orthe openings 312 may be used to hold an intravenous tube 307 in place,see FIG. 59, or the dressing 300 simply be used to hold an incision 17closed without resorting to the application of stitches 17 a, see FIG.60.

Referring to FIGS. 61 through 66 and FIGS. 70 through 76 a variety ofalternative designs of the dressing 300 may be seen. All the dressings300 disclosed operate on the same principles previously disclosed butthey are shown to illustrate that shape of the latex 321 and theopenings 312 may varied without departing from the invention describedherein. Also, illustrated is the fact that the pad 314 and the material323 may vary in size and shape. Further, the radius or arcuate section330 may be varied in shape to provide for uniform distribution oftension across the latex 321.

Referring to FIGS. 67 through 69 another embodiment of the presentinvention may be seen wherein the latex 321 includes a ring section 347of material 323. Coupled to the ring section 347 is the latex 321 and aclear urethane material 345 of the type commonly suitable for medicalapplications; alternative materials may be used such as any suitablebreathable material depending upon the application desired. Asillustrated by FIG. 68 the ring section 347 is comprised of a layer ofTYVEC brand material 323, a layer of adhesive 327, a layer of latex 321having openings 316 which function in the same manner as openings 304,another layer of adhesive 327, another layer of TYVEC brand material323, the clear material 345, and a colloid adhesive 349. This structurecreates a stable space 351 over the desired area and the colloid 349isolates the area and prevents stretching of the epidermis 11 under thespace 351 so that the wound or other desired area is kept in an isolatedenvironment which may be observed through the material 345. The colloid349 and the material 345 isolating the wound from external sources ofinfection.

Referring to FIGS. 85 and 86 another alternative design of the presentinvention may be observed. In this embodiment the center section is abreathable membrane 372 of a type commonly used for dressingapplications. Perforations 308 allow the dressing to be broken apart toform a plurality of anchor sections 301. Openings 373 are provided inthe member 372 to prevent tearing of the membrane 372. A locking section317 a, previously described, is provided. Referring to FIGS. 78 and 79the cross-sectional construction may be seen to include at top layer ofmaterial 323, a layer of adhesive 327, latex 321 including openings 304,adhesive 327, material 323, adhesive 327, the breathable membrane 372,and a colloid adhesive 349. The dressing 300 capable of covering adesired area of an epidermis 11 and substantially isolating that areafrom external contamination.

Referring now to FIGS. 83, 84, and 77 the same structures as shown inFIGS. 85 and 86, 78 and 79 are shown with the exception that thebreathable membrane 372 has been eliminated so that there is only anopening 370. This dressing 300 is believed to have application where itis desired that the wounded or burnt area of the epidermis be exposed toair. Since the spring action of the latex 321 will press down on theepidermal area surround the wound or burn within the opening 370 this isbelieved to cause the wound or burn to well up and thus receive maximumexposure.

Referring now to FIG. 80 another alternative embodiment similar to thestructure disclosed in FIG. 78 with the exception that the breathablemembrane 372 has been replaced with an sealed membrane 399 such as aurethane commonly used to hold IV type fluids. Extending through thismembrane 399 is an input port and an output port. This dressing 300could be used to seal a wound from external contamination but allow thewound to be irrigated or medicine applied or tissue samples taken.

Referring now to FIGS. 87 and 88 another embodiment is illustratedshowing a resealable closure 380. The closure or zipper 380 may bisectthe dressing or extend only partially across the dressing 300. Theclosure 380 is provided to allow access to the wound or burn or otherarea without having to remove and reapply the bandage.

Referring now to FIGS. 89-93 various applications of the dressings 300described herein may be seen to be illustrated in use on a human being.

Referring now to FIGS. 94-96 another embodiment, similar to thestructure disclosed in FIGS. 35-52, and 61-76 is shown. As seen, thedressing structure 300 is comprised of a multiple layer or laminatedmaterial 302 at anchor sections 301 and 303, and a multiple layer orlaminated material 302 a at its center section 325. As may be seenparticularly in FIG. 96, the laminated material 302 includes a topsurface or layer 315 made of TYVEC brand material or spun silk, and abottom surface or layer 319 comprised of a hypo-allergenic adhesivelayer 327, covered with a silicone release liner 30. The laminatedmaterial 302 preferably further includes a channel 313 into whichmargins 317 of an elastic member 321 are engaged, thereby locating themargins 317 between the top surface layer 315 and the adhesive layer327. The elastic member 321 may be formed of latex rubber or othersuitably elastic material. The margins 317 preferably includes openings304 which allow the adhesive layer 327 to extend through the openings304 to communicate with the top surface layer 315, thereby coupling thetop surface layer 315 to the margins 317. This action effectively locksthe elastic material 321 into position so that it may not be easilyremoved by tension when stretched.

Still referring to FIGS. 94-96, the center section 325 may be observedto include a stabilizing section 323. The stabilizing section 323 may befabricated of TYVC brand material, spun silk, or any other suitablematerial. The stabilizing section 323, is preferably bonded to the padmember 314 a and elastic member 321 via openings 316, in elastic member321 which allow an adhesive layer 327 a to communicate through theopenings 316 with section 323. This action couples the stabilizingsection 323, elastic member 321 and pad member 314 a at the stabilizingsection 323 whereby the pad member 314 a is suspended by the elasticmember 321 between the anchor sections 301, 303.

The stabilizing section 323 may be further provided with openings 306which allow easy dispersal of medicaments or other substances (notshown) through the pad member 314 a to an epidermis (not shown in theseviews). It is further to be noted that the pad member 314 a may beformed of a hydrophilic material (as shown), gauze, or any othersuitable material. Furthermore, it may be noted that a silicone surfacematerial 600 may be applied to any pad member surface, to aid in shearreduction on the epidermal surface to which the device is affixed.Alternatively, the pad member may be entirely replaced by a siliconesurface material (not shown). Additionally, previously describedembodiments may also include a hydrophilic material as part of the pador center section construction.

The dressing structure 300 seen in FIGS. 94-96 may be further observedto include a barrier layer 500. The barrier layer 500 preferablyoverlays at least a portion of the adhesive layer 327, between theadhesive layer 327 and the elastic member 321. As is seen particularlyin FIG. 96, the adhesive layer 327 may preferably include a distal end502 and a proximal end 504. The barrier layer 500 preferably overlays aportion at the proximal end 504 of adhesive layer 327. The barrier layer500 reduces the lifting or peel force on the adhesive layer 327 therebyincreasing the stability of the bond between the adhesive layer 327 andan epidermis (not shown) when the dressing structure 300 is applied andthe elastic member 321 is stretched between the anchor sections 301,303. As illustrated in previous embodiments, when this embodiment isapplied over a wound or other predetermined area, the elastic member 321acts much as a leaf spring and applies a positive pressure downwardthrough the pad member 314 a. The additional use of a hydrophilic padmaterial as shown in the embodiment of FIGS. 94-96 works in combinationwith the positive pressure downward pressure to effectively maintaincontact of the pad member 314 a with the predetermined area.

As seen in FIGS. 94-96, openings 312 may be located in a tensionadjustment section 412 of the elastic member 321. As mentionedpreviously with regard to other embodiments, as the tension adjustmentsection 412 of the elastic member 321 is stretched to apply the dressingstructure 300, the openings 312 will become distorted. The greater thestretching, the greater the tension applied to the elastic member 321.In this way the amount of tension applied to the elastic member 321 maybe seen, allowing a person applying the dressing to keep the pressurerelatively constant.

Referring now to FIGS. 97-100 another embodiment of the presentinvention may be seen. Similarly to the embodiment seen in FIGS. 94-96,the dressing structure 300 a seen in these views is composed of amultiple layer or laminated material 302 at anchor sections 301 a and303 a, and a multiple layer or laminated material 302 a at its centersection 325. However, as seen particularly in FIG. 99, anchor section301 a includes a plurality of loop members 506. Anchor section 303 apreferably includes at least one laterally extending portion 510 havinghook members 508 arranged to be fastened to the loop members 506 onanchor section 301 a. This arrangement allows the dressing structure 300a to be easily affixed to a limb 12, as seen in FIG. 100, and allows auser to inspect or clean the wound without removing the adhesive layerfrom the skin surface. As may be seen particularly in FIG. 99, thelaminated material 302 at anchor section 301 a includes a top surface orlayer 315 made of TYVEC brand material, spun silk, or similar material.The top surface 315 includes a plurality of loop members 506, asmentioned. The bottom surface or layer 319 is comprised of ahypo-allergenic adhesive layer 327, covered with a silicone releaseliner 30. The laminated material 302 at anchor section 303 a includes atop surface layer similar to that of anchor structure 301 a, butincluding a laterally extending portion 510 having hook members 508arranged to bus fastened to the loop members 506 on anchor structure 301a. The laterally extending portion may be attached to top surface 315 byconventional means such as stitching, adhesive, or by way ofcorresponding loop members on anchor structure 301 a, as shown. Further,the laminated material 302 at anchor section 303 a preferably includes abottom surfaces 319 of a TYVC brand material, spun silk, or any othersuitable material, attached by way of an adhesive layer 327, rather thanthe adhesive layer covered with a release liner as shown at anchorsection 301 a. The laminated material at anchor structures 301 a and 303a preferably includes a channel 313 into which margins of elastic member321 are engaged as discussed in connection to the embodiment of FIGS.94-96.

Similarly to the embodiment of FIGS. 94-96, the device illustrated inFIGS. 97-100 may further include a barrier layer 500. The barrier layer500 preferably overlays a portion of the proximal end 504 of theadhesive layer 327 at anchor section 301 a.

Illustrated in FIGS. 101-104 is another alternative embodiment dressingstructure 300 b may be seen. As in the embodiment shown in FIGS. 97-100,the device of FIGS. 101-104 is provided with a plurality of loop members506 and hook members 508. However, as seen the laminated material 302 atanchor sections 301 a, 303 a is provided with a bottom surface 319 ofTYVC brand material, spun silk, or any other suitable material, ratherthan an adhesive layer as previously illustrated. This arrangementallows the dressing structure 300 b to be secured to an epidermis (notshown) without the use of adhesive which, over prolonged use, may becomean irritant to sensitive application sites.

Referring now to FIGS. 103 and 104 another alternative embodiment of thedressing structure 300 a may be seen. As illustrated, the devicepreviously disclosed with reference to FIG. 35 is illustrated butincluding a non-adhesive barrier layer 500 coextensive with andoverlaying a portion of the adhesive layer 327. The device furtherincludes a pad member 314 a composed of a hydrophilic material. Whilenot illustrated as such, it is to be understood that the device may befabricated with a barrier layer 500 while including a pad member 314 ofany conventional material, such as gauze.

Illustrated in FIGS. 105 and 106 is another alternative embodiment, seenas the device previously disclosed with regard to FIG. 53. In thisembodiment, the dressing 300 a is composed of a piece of elastic member321, such as latex, having two ends to which anchors 310 a and 303 b arerespectively attached. The ends of the elastic member 321 are simplysandwiched between the top surface member 315 and the bottom surfacelayer 319. A stabilizing section member 323 is adhered across the centersection 325 of the elastic member 321, and a pad member 314 a is adheredto the underside of the elastic member 321. As illustrated, the devicemay be further provided with a barrier layer 500 as discussed withregard to previous embodiments. The barrier layer is preferably locatedbetween adhesive layer 327 and elastic member 321 at a proximal endportion 504 of adhesive layer 327. The pad member 314 a may befabricated of a hydrophilic material as shown or any other suitablematerial.

Seen in FIGS. 107 and 108 is another embodiment of the dressingmechanism 300 a, but similar to the embodiment disclosed in FIGS. 55-60.In this embodiment the entire elastic member 321 is essentiallycomprised of tensioning section 412 having openings 312. The variouscomponents function as previously described, however the device includesthe feature of a non-adhesive barrier layer 500. As described withregard to FIGS. 95-106, the barrier layer 500 is preferably locatedbetween adhesive layer 327 and elastic member 321 at the proximal endportion 504 of adhesive layer 327.

FIGS. 109-113 illustrate an alternative embodiment including multiplepad members 314 a and the use of a barrier layer 500 between theadhesive layer 327 and elastic member 321 as described previously.

The foregoing is considered as illustrative only of the principles ofthe invention. Furthermore, since numerous modifications and changeswill readily occur to those skilled in the art, it is not desired tolimit the invention to the exact construction and operation shown anddescribed. While the preferred embodiment has been described, thedetails may be changed without departing from the invention, which isdefined by the claims.

1. A dressing comprising: a plurality of anchor structures, a treatmentstructure, and an elastic material; said elastic material extending fromone of said plurality of anchoring structures to said treatmentstructure; said elastic material including a first coupling section anda second coupling section, said elastic material being coupled to saidone of said plurality of anchoring structures at said first couplingsection and to said treatment structure at said second coupling section,and wherein at least one of said plurality of anchor structures includesa first side and a second side, said second side including a pluralityof hook members arranged to be fastened to loop members of a hook andloop fastener, and wherein a second one of said plurality of anchorstructures includes at least one side having a laterally extendingportion, said laterally extending portion including at least one sidehaving a plurality of loop members arranged to be fastened to the hookmembers on said at least one of said plurality of anchor structures. 2.The dressing of claim 1 wherein said plurality of anchoring structureseach include a first side having, an adhesive located thereon.
 3. Thedressing of claim 1 wherein said elastic material includes a pluralityof openings located at predetermined positions.
 4. The dressing of claim3 wherein said openings have at least one predetermined shape.
 5. Thedressing of claim 4 wherein said shape is oriented in a predeterminedmanner and direction.
 6. The dressing of claim 1 wherein said one ofsaid plurality of anchor structures includes a slit structure forreceiving said first coupling section of said elastic material.
 7. Thedressing of claim 6 wherein said first coupling section includes aplurality of openings extending there through.
 8. The dressing of claim7 wherein said slit structure includes at least one adhesive materialand said first coupling section includes a first surface and a secondsurface; said adhesive material engaging said first surface, said secondsurface, and extending through said openings; said adhesive materialsecuring said coupling section to said slit structure.
 9. The dressingof claim 1 wherein the treatment structure is comprised of a gauzematerial.
 10. The dressing of claim 1 wherein the treatment structureincludes a plurality of air vents.
 11. The dressing of claim 1 whereinthe treatment structure includes at least one opening.
 12. The dressingof claim 1 wherein the treatment structure includes a transparent walllocated at a predetermined area.
 13. The dressing of claim 1 whereinsaid treatment structure includes at least one input port and one outputport.
 14. The dressing of claim 1 wherein said treatment structure isimpregnated with at least one predetermined medicine.
 15. The dressingof claim 1 wherein said treatment structure comprises a hydrophilicmaterial.
 16. A dressing comprising: a plurality of anchor structures, atreatment structure, and an elastic material; at least one of saidplurality of anchor structures having a first side and a second side;said elastic material extending from said at least one anchor structureto said treatment structure; said elastic material including a firstcoupling section and a second coupling section, said elastic materialbeing coupled to said at least one anchoring structure at said firstcoupling section and to said treatment structure at said second couplingsection; at least one adhesive layer, said at least one adhesive layerhaving a first adhesive side and a second adhesive side; said firstadhesive side being coupled to said first side of at least one of saidplurality of anchor structures; said at least one adhesive layerincluding a distal end and a proximal end; a barrier layer, said barrierlayer overlaying at least a portion of said first adhesive side; said atleast a portion of said first adhesive side located proximate saidproximal end of said at least one adhesive layer.
 17. The dressing ofclaim 16 wherein said treatment structure is comprised of a hydrophulicmaterial.
 18. The dressing of claim 16 wherein said second side of saidat least one of said plurality of anchor structures includes a pluralityof hook members arranged to be fastened to loop members of a hook andloop fastener.
 19. The dressing of claim 18 further including a secondof said plurality of anchor structures, said second of said plurality ofanchor structures including at least one side having a laterallyextending portion, said laterally extending portion including at leastone side having a plurality of loop members arranged to be fastened tothe hook members on said at least one anchor structure.
 20. The dressingof claim 18 wherein said treatment structure is comprised of ahydrophilic material.